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An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01716858
Recruitment Status : Completed
First Posted : October 30, 2012
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
Kenji Hashimoto, Chiba University

Study Description
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Brief Summary:
Accumulating evidence suggests a role of oxidative stress in the pathophysiology of schizophrenia. The potent antioxidant sulforaphane (SFN) is an organosulfur compound derived from a glucosinolate precursor found in cruciferous vegetables such as broccoli, Brussels sprouts and cabbage. The protection afforded by SFN is thought to be mediated via activation of the NF-E2-related factor-2 (Nrf2) pathway and subsequent up-regulation of phase II detoxification enzymes and antioxidant proteins, through an enhancer sequence referred to as the electrophilic responsive element or antioxidant responsive element. Recently, we reported that SFN could attenuate behavioral abnormalities in mice after the NMDA receptor antagonist phencyclidine. Considering the potent antioxidant effects of SFN, we have a hypothesis that SFN would be a potential therapeutic drug for schizophrenia. The purpose of this study is to determine whether SFN-rich broccoli sprout extract have beneficial effects in patients with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Dietary Supplement: Sulforaphane-rich Broccoli Sprout Extract Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sulforaphane-rich Broccoli Sprout Extract for Schizophrenia
Study Start Date : October 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: A single-arm study Dietary Supplement: Sulforaphane-rich Broccoli Sprout Extract


Outcome Measures
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Primary Outcome Measures :
  1. Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Change from baseline in PANSS scores at 8-weeks ]

Secondary Outcome Measures :
  1. Cognition using CogState Research Battery [ Time Frame: Change from baseline in the scores of the battery at 8-weeks ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Schizophrenia for DSM-IV TR criteria
  • Patients are treated with an antipsychotic drug (risperidone, olanzapine, quetiapine, perospirone, aripiprazole, blonanserin, paliperidone).
  • Patients are stable for 4-weeks for antipsychotic medication.

Exclusion Criteria:

  • Patients treated with clozapine
  • Patients treated with two or more antipsychotic drugs
  • Pregnant or breast-feeding women
  • Patients treated with sulforaphane for more than 8-weeks in the past.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716858


Locations
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Japan
Chiba University Hospital
Chiba, Japan, 260-8670
Sponsors and Collaborators
Chiba University
Investigators
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Study Chair: Masaomi Iyo, MD, PhD Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Kenji Hashimoto, Sulforaphane for Schizophrenia, Chiba University
ClinicalTrials.gov Identifier: NCT01716858    
Other Study ID Numbers: Chiba_SFN_Openstudy2012
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: October 2012
Keywords provided by Kenji Hashimoto, Chiba University:
Schizophrenia
Sulforaphane
Psychosis
Cognition
 Oxidative stress
Antioxidant
Anti-inflammatory
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Sulforaphane
 Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents